Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy

July 28, 2023 updated by: Zhijun Bao, Fudan University

Aim of the study :

To evaluate the effect and safety of "Heidelberg Triangle" dissection (TRIANGLE operation) combined with Pancreatoduodenectomy or Distal Pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer .

Methods :

Patients who underwent pancreatoduodenectomy or Distal Pancreatectomy between 01 September 2016 and 30 December 2022 will be included in this retrospective analysis. 3D reconstruction is performed with preoperative enhanced CT, then the region of "Heidelberg Triangle" is categorized . The operation is completed by the same operation team. According to the operation mode, patients were divided into TRIANGLE group and non-TRIANGLE group and And followed up until recurrence, death or missed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The "Heidelberg Triangle" is an anatomical area composed of Common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV).

This area is considered to be the common site of recurrence after pancreatic surgery.

Recent studies have shown that TRIANGLE operation can improve the state of the cutting edge and has potential value in improving the prognosis. However, the data on recurrence and survival rate of pancreatic cancer and periampullary cancer after TRIANGLE operation are insufficient.

The aim of the present study is to evaluate the effect and safety of "Heidelberg Triangle" dissection combined with Pancreatoduodenectomy or Distal Pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer .

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Huadong Hospital Affiliated to Fudan University
        • Contact:
        • Principal Investigator:
          • Jiahao Chen, M.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed by preoperative imaging and auxiliary examination as resectable or borderline resectable pancreatic malignant tumor or periampullary carcinoma who underwent undergo pancreatoduodenectomy or distal pancreatectomy, with or without TRIANGLE operation

Description

Inclusion Criteria:

  1. Patients diagnosed by preoperative imaging and auxiliary examination as resectable or borderline resectable pancreatic malignant tumor or periampullary carcinoma who underwent pancreatoduodenectomy or distal pancreatectomy, with or without TRIANGLE operation.
  2. Patients who have no serious abnormalities of blood system, heart and lung function and immune deficiency and can tolerate surgery.
  3. Be able to comply with the research visit plan and other program requirements

Exclusion Criteria:

  1. Patients accompanied by other systemic malignancies.
  2. Central nervous system disease, mental disease, unstable angina pectoris, congestive heart failure, serious arrhythmia and other uncontrollable serious diseases, unable to tolerate surgery.
  3. Pregnant and lactating women.
  4. Any condition that may impair the safety of patients or the integrity of research data, including serious medical risk factors, medical conditions, and laboratory abnormalities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PD(TRIANGLE)
Patients with pancreatic head cancer or periampullary cancer underwent "Heidelberg Triangle" dissection (TRIANGLE operation) combined with Pancreatoduodenectomy and standard lymphadenectomy
Procedure: TRIANGLE operation
dissection the region composed of common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV)
PD(non-TRIANGLE)
Patients with pancreatic head cancer or periampullary cancer underwent pancreatoduodenectomy with standard lymphadenectomy
DP(TRIANGLE)
Patients with carcinoma of the body and tail of the pancreas underwent "Heidelberg Triangle" dissection (TRIANGLE operation) combined with distal pancreatectomy and standard lymphadenectomy
Procedure: TRIANGLE operation
dissection the region composed of common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV)
DP(non-TRIANGLE)
Patients with carcinoma of the body and tail of the pancreas underwent distal pancreatectomy with standard lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival (RFS)
Time Frame: up to 72 months
from the date of surgery to the first radiographic or pathologic evidence of recurrence.
up to 72 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to 72 months
from the date of diagnosis to death or last follow up
up to 72 months
Surgical Morbidity
Time Frame: 90 postoperative days
including postoperative pancreatic fistula (B/C), bile leakage (B/C), delayed gastric emptying (B/C), postpancreatectomy haemorrhage (B/C), postoperative chyle leak (B/C), postoperative intra-abdominal infection.
90 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Chongyi Jiang, PhD, Huadong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Huadong Hospital to Fudan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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